Scancell Receives GBP250,000 emda Grant

Scancell Holdings plc, the parent company of Scancell Limited (`Scancell'), the developer of therapeutic cancer vaccines based on its patented ImmunoBody(tm) platform, is pleased to announce that it has been awarded a £250,000 Grant for Research and Development (`GRD') by the East Midlands Development Agency (`emda'). The GRD will be used towards the costs of progressing Scancell's SCIB1 ImmunoBody DNA vaccine as it commences Good Manufacturing Practice (`GMP') production in 1Q2009 and applies for Clinical Trial Authorisation (`CTA') to commence clinical trials of SCIB1 in the UK in 1Q2010.

Scancell is developing SCIB1, a DNA vaccine for the potential treatment of late-stage melanoma cancer patients. There are 8000 new cases of melanoma every year in the UK with 1800 deaths per year. Early stage melanoma is often cured by surgery but advanced disease has a very poor prognosis with late stage (stage IV) disease having a median survival of approximately 6 months. SCIB1 was developed using Scancell's ImmunoBody(tm) technology and is engineered to express the TRP-2 and gp100 cytotoxic T-cell epitopes from tumour antigens. In animal models, SCIB1 prevented the development of lung metastases and significantly inhibited the growth of established tumours.

The emda grant will be used to help fund the preparatory programme for phaseI/ IIa clinical trials that are anticipated to commence in 2010. The programme includes: optimisation of the ImmunoBody(tm); GMP process manufacture, formulation, stability and scale-up; pre-clinical efficacy and safety testing, and; toxicological assessment. The data derived from these studies will be utilised by Scancell in order to obtain CTA to allow the first clinical trial of SCIB1 in melanoma patients.

emda is one of nine Regional Development Agencies in England, set up in 1999 to bring a regional focus to economic development. Its primary goal is to increase the economic growth of the region while reducing disparities between the East Midlands and other English regions. The key role of emda is to be the strategic driver of sustainable economic development, working in partnership with public, private and voluntary organisations to deliver the goals of the Regional Economic Strategy.

David Evans, Chairman of Scancell, commented:

"We are delighted to have received a £250,000 grant from emda, the proceeds of which will be used to further progress SCIB1 and to further explore the manifold opportunities we expect that our ImmunoBody(tm) platform will present for the treatment of cancer, and other serious diseases. We are also pleased to be recognised by emda as a contributor to the economic growth prospects of the East Midlands region and appreciate the support that emda is providing towards building our business and the successful development of our innovative technology."

John O'Reilly, Business Support Director at emda, commented:

"Scancell is just the kind of innovative company that we are looking to support through the Grant for Research and Development. The grant will help it to develop a revolutionary new treatment which will not only help thousands of people affected by cancer, but which will also enable the business to develop and grow, creating new jobs for the region."

The Directors of the issuer accept responsibility for this announcement.

GMP Manufacture Deal With Cobra

Scancell Holdings Plc, the parent company of Scancell Limited (`Scancell'), the developer of therapeutic cancer vaccines based on its patented ImmunoBody(tm) platform, is pleased to announce that it has signed a deal with Cobra Biomanufacturing Plc (`Cobra Biomanufacturing') for Good Manufacturing Practice (`GMP') manufacture of its SCIB1 DNA vaccine. Scancell plan to commence clinical trials of SCIB1 in the UK in 1Q2010.

Scancell is developing SCIB1, a DNA vaccine for the potential treatment of late-stage melanoma cancer patients. There are 8000 new cases of melanoma every year in the UK with 1800 deaths per year. Early stage melanoma is often cured by surgery but advanced disease has a very poor prognosis with late stage (stage IV) disease having a median survival of approximately 6 months. SCIB1 was developed using Scancell's ImmunoBody(tm) technology and is engineered to express the TRP-2 and gp100 cytotoxic T-cell epitopes from tumour antigens. In animal models, SCIB1 prevented the development of lung metastases and significantly inhibited the growth of established tumours.

Cobra Biomanufacturing is an AIM-listed contract manufacturer of biopharmaceuticals that is compliant with cGMP standards worldwide.

David Evans, chairman of Scancell, commented:

"We are delighted to sign a deal with Cobra Biomanufacturing to manufacture our SCIB1 DNA vaccine. That we are commencing GMP manufacture of SCIB1 on schedule is testament to the progress the Company continues to achieve."

Simon Saxby, Chief Executive of Cobra Biomanufacturing said:

"We are very pleased to be have been selected by Scancell as a result of Cobra's abilities and reputation as a leading cGMP compliant manufacturer of DNA. This agreement also underscores Cobra's long term commitment to the manufacture of therapeutic vaccines."

The Directors of the issuer accept responsibility for this announcement.  

Interim Results for the six month period to 31 October 2008

The Directors of Scancell Holdings plc, the parent company of Scancell Limited (‘Scancell’),
the developer of cancer vaccines based on its patented ImmunoBody™ platform, are pleased
to announce the interim results for Scancell for the six month period ended 31st October 2008
(‘the period’).

Highlights:

  • Admitted to Plus markets on 24 September 2008 and raised £1.559,502 on 24th September 2008
  • Issue of equity raised £43,999.8 on the 19th of December 2008
  • Following the placing of shares in September, the Company has £2,220,479 cash reserves
  • Continued make good progress towards its goal of starting Phase 1 clinical trials with SCIB1 in 2010
  • Agreement to license key components of SCIB1 from National Institute for Health (‘NIH’) in the final phase of negotiation
  • Negotiations to secure development and commercial rights to an injection device to deliver SCIB1 to patients progressing wel
  • Experienced Development Advisor appointed for SCIB1
  • Presented at the Genesis 2008 Oncology Showcase

David Evans, Non-Executive Chairman of Scancell, commented:

“I am delighted to report a very successful first six months as a public company. In 2008, we raised £1.6m in conjunction with being admitted to Plus markets. The funds raised will provide the ability to further develop Scancell’s core technology; the ImmunoBodyTM platform and to achieve its aim of starting Phase 1 clinical trials of SCIB1 in 2010.”

For further information contact:

Company:
Scancell Holdings Plc  -  Professor Lindy Durrant/Dr Richard Goodfellow  -  Tel: 020 7245 1100

Corporate Advisers:
St Helen's Capital Plc  -  Duncan Vasey/Barry Hocken  -  Tel: 020 7628 5582

Financial PR:
Hansard Group  -  Adam Reynolds/Vicky Krause  -  Tel: 020 7245 1100

View the full results

Issue of Equity

The Directors of Scancell are pleased to announce that on 19 December 2008, the Company issued 73,333 new ordinary shares of 1p each in lieu of advisory fees relating to the admission of the Company onto the PLUS-quoted market at a price of 60 pence per share.

The trading of the new ordinary shares on PLUS is expected to commence on 22 December 2008.

Following the issue of shares as detailed above the total number of ordinary shares in issue as at 19 December 2008 will be 10,275,551 ordinary shares. The total Directors' Shareholding as a result of the Issue of Equity is 2,627,892 ordinary shares representing 25.57% of the current issued share capital.

The Directors of the issuer accept responsibility for this announcement.

Notice of Results

Notification of Interim Results

Scancell Holdings Plc, the developer of therapeutic cancer vaccines based on its patented ImmunoBody(tm) platform, today announces that it will release its Interim Results for the six months ended 31 October 2008 during the week commencing
Monday 12th January 2009.

Audited Final Results for the Year Ended 30 April 2008

The Directors of Scancell Holdings Plc are pleased to announce the audited results for Scancell Limited for the year ended 30 April 2008.

Chairman's Statement

In the last financial year we have consolidated our position in relation to the science and the finances of the Company.

In November, I was elected Non-Executive Chairman and brought my considerable experience in listed companies to the board. A decision was made at the beginning of 2008 to list the Company on the PLUS Market (www.PLUSmarketsgroup.com) and successfully achieved on the 24th of September 2008.This has attracted new finance to progress our lead product SCIB1 into the clinic and continue the development of the ImmunoBody platform. A decision was made by the directors that they are not paying a dividend for the period.

We look forward to updating shareholders with developments over the coming months.

For the full report click here

Scancell sells antibody pipeline to Peptech

Key points

  • Acquires additional antibody assets
  • Second M&A transaction in 2006
  • Strengthens oncology franchise
  • Purchase consideration of GBP 2 million plus a contingent payment of GBP 2.85 million

Australian biotechnology company Peptech Limited (ASX:PTD) continues to pursue its determined merger and acquisition strategy today announcing its second acquisition for the calendar year with the acquisition of the antibody assets of UK based Scancell Limited through its newly established UK subsidiary, Peptech UK Limited.

The acquisition, in which Peptech assumes control of cancer therapeutic antibodies and related intellectual property from Scancell, provides further validation of Peptech's aggressive growth strategy announced in January this year. The acquisition is consistent with its internationalisation strategy and builds upon the recently announced intention to list on AIM in London.

Peptech acquired Scancell’s two pre-clinical lead cancer-related antibodies, SC101 and SC104, along with a suite of additional anti-cancer antibodies in the early stages of development.

SC101 and SC104 target colorectal cancers, a significant unmet medical need with a market estimated to exceed US$3.2 billion.

Peptech Chief Executive Officer Dr John Chiplin said the additional antibodies substantially strengthened Peptech’s existing cancer product pipeline and substantiate further the company’s recent decision to list on AIM in order to strategically exploit opportunities in Europe.

“The two newly acquired lead antibodies have demonstrated promising preclinical results that can be correlated with direct cancer cell killing properties,” Dr Chiplin said.

“It is our intention to utilise these antibodies to provide additional strength to our existing oncology development program, which includes our relationship with Biosceptre International, to create a world-class anti-cancer franchise.”

“This is an excellent deal for Scancell” said Scancell’s scientific founder, Prof. Lindy Durrant. “The deal with Peptech will enhance the prospects of these exciting antibodies reaching the clinic and improving cancer treatment. Moreover it will allow Scancell to focus its efforts on its innovative ImmunoBody cancer vaccine programme"

The initial consideration will be a cash payment of GBP2 million. Peptech will make a further payment of GBP2.85 million upon any of the acquired products reaching a Phase I clinical trial, to be paid by either cash or shares, at Peptech’s discretion.

Occurring just six months after the acquisition of Promics which strengthened Peptech’s anti-inflammatory franchise, the Scancell acquisition provides Peptech with expanded options in the treatment of various cancers.

“There is a substantial medical need for new cancer products across the world and these new antibodies will provide us with the ability to enter large and growing markets for new therapies in lucrative cancer markets currently estimated to exceed US$30 billion,” Dr Chiplin said.

“By further developing the more advanced lead compounds in our Sydney facility, and continuing the research effort in the UK to further evaluate the suite of less advanced anti-cancer antibodies, we build upon Peptech's strong expertise in evaluating and developing antibody products.”

About Peptech:

Peptech Limited focuses on the research and development of peptides and proteins in the areas of human pharmaceuticals and animal health. The company is positioned to become a globally recognised leader in biopharmaceutical development.

For further information: www.peptech.com

About Colorectal Cancer:

Colorectal cancer is the cancer with second or third highest incidence in both US and Europe. About 155,000 new cases of colorectal cancer and 24,000 cases of stomach cancer are diagnosed each year in the USA, in Europe about 381,000 cases of colorectal cancer were diagnosed in 2004. The market for drugs treating colorectal cancer was about $US3.2 billion in 2004, about 13% of global oncology sales.

GTC Biotherapeutics and Scancell Collaborate on SC101 Antibody

FRAMINGHAM, MA and NOTTINGHAM, UK – July 28, 2005 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) and Scancell Limited (“Scancell”) announced that they have signed a collaboration agreement to evaluate the expression of Scancell’s SC101 anti-cancer monoclonal antibody (MAb) using GTC’s transgenic production platform. Their agreement contemplates that both companies will work toward the establishment of a definitive agreement for the potential clinical development of SC101.

“We look forward to demonstrating the value offered by transgenic technology for the production of antibody products such as SC101,” noted Gregory Liposky, GTC’s Senior Vice President, Operations. “GTC’s technology offers significant advantages for the development of proteins that are projected to be required in large commercial production quantities, when approved, and we believe we can assist Scancell in realizing that potential value.”

Commenting on the agreement, Michael Capaldi, Chief Executive Officer of Scancell, said: "We are very pleased to be working with GTC. This agreement offers Scancell the opportunity to establish development of what we believe will be a very large scale product at significantly lower capital investment."

SC101 is a MAb that targets Lewisy/b. Lewisy/b is a cell surface carbohydrate blood group antigen whose xpression is very low in normal tissue but is over-expressed on breast, colorectal, endometrial, kidney, lung, pancreas and stomach tumours. Mouse antibodies recognizing Lewisy/b have induced tumor cell death and inhibited growth of various tumor lines. In animal studies, tumor growth was inhibited by anti-Lewisy/b antibodies alone, and especially when combined with 5-fluorouracil, an antimetabolite that disrupts cancer cell growth.

About GTC Biotherapeutics

GTC Biotherapeutics is a leader in the development, production, and commercialization of therapeutic proteins through transgenic animal technology. GTC currently has five products in its internal pipeline and a portfolio of external program production opportunities. GTC’s lead program is ATryn®, its recombinant form of human antithrombin. A Market Authorization Application is under review by the European Medicines Agency for the use of ATryn® in patients with a hereditary antithrombin deficiency. In addition to the ATryn® program, GTC is developing a recombinant human alpha-1 antitrypsin, a recombinant human albumin, a malaria vaccine, and a CD137 antibody to stimulate the immune system as a potential treatment for solid tumors. In its external programs, GTC's technology is used to develop transgenic production of its partners’ proprietary products, including both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional recombinant production systems. One of the external programs is in clinical trials with a transgenically produced product. Additional information is available on the GTC web site, http://www.gtc-bio.com.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the prospects for anticipated expression of SC101 in a transgenic production system and for a definitive agreement with Scancell for further development of transgenic production for SC101. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K and its other periodic reports as filed with the Securities and Exchange Commission, including the risks and uncertainties inherent in the development of transgenic expression of compounds and the actions of collaboration partners. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law. GTC specifically disclaims responsibility for information describing Scancell, its business and SC101, other than the collaboration with GTC.

About Scancell

Scancell Ltd is a company focused on the discovery and development of products that harness the immune system in a unique way to treat or prevent cancer. The Company, which currently employs 12 individuals, has secured £4.6million of private equity and commercial funding. The Company has built an early stage product pipeline based upon two platforms: directly killing MAbs (‘killer’ MAbs) and its patent protected ImmunoBody® vaccine platform. ‘Killer’ MAbs are raised against ‘cocktails’ of primary human tumours resulting in MAbs that recognize clinically relevant targets. The Company screens for MAbs that directly kill tumour cells (i.e. without the need for antibody-dependant cellular cytotoxicity (ADCC) or complement mediated cytotoxicity (CDC)) and have an additive and/or synergistic killing effect in the presence of chemotherapeutics. Scancell has three such products in pre-clinical development and a number of further ‘killer’ MAbs in research. Scancell’s ImmunoBody® technology uses human antibodies as vectors to target clinically relevant T-cell epitopes to activated dendritic cells via the high affinity CD64 receptor thereby initiating cellular immunity against cancers or chronic infectious diseases. For more information about Scancell visit www.scancell.co.uk

Except for the historical information presented herein, matters discussed in this press release are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements, e.g. unforeseen exchange rate and interest rate fluctuations, delayed or unsuccessful development projects.

Statements that are not historical facts, including statements preceded by, followed by, or that include the words "believes"; "anticipates"; "plans"; "expects"; "estimates"; or similar statements are forward-looking statements. Scancell is not under an obligation to up-date statements regarding the future following the publication of this release; nor to confirm such statements in relation to actual results, unless this is required by law.